MediGenix PO6L User manual

Instrucns  User
Thank you for purchasing the MediGenix Classic Fingerp Pulse Oximeter.
This user manual is wrien and compiled in accordance with the council direcve MDD93/42/EEC for medical
oximeters and harmonised standards. In case of modicaons and soware upgrades, the informaon
contained in this document is paent to change without noce.
The user manual describes the oximeter’s features, requirements, main structure, funcons, specicaons,
correct methods for transportaon, installation, usage, operaon, repair, maintenance and storage as well as
the safety procedures to protect both the user and the equipment. Refer to the respecve secons for details.
Please read the user manual carefully before using this oximeter. The operang procedures described below
should be strictly followed. Failure to do so may cause abnormal results, equipment damage and human injury.
The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring
abnormality, human injury and equipment damage due to user negligence regarding the operaon instrucons.
The manufacturer’s warranty does not cover such faults caused by user error or negligence.
Owing to connuous oximeter development there may be slight dierences between this manual and the
oximeter you have received.
This is a medical oximeter, which can be used repeatedly.
WARNING:
An uncmftable  painful feeling may appear if the ximeter is used nusly, especially f
micrirculati barrier paents. It is remmended that the ximeter is t applied tthe same nger
fmre than 2 hurs at a me.
The ximeter cant be clippetender, swlen  edema ssue.
The infrared light emied frm the ximeter is harmful tthe eyes, t stare at the light.
Dt use the ximeter  ngers that have nail lish, false nails, gel nails  ther makeup as this will
interfere with the results.
Ensure the ngernail is t t lg.
Please refer tthe relave literature t clinical restrics and cautis.
This ximeter ist intended ftreatment.
Cauon: The user manual is published by our company. All rights reserved.
1 Safety
1.1 Instrucns fsafe pera
Check the oximeter and accessories regularly to ensure there is no visible damage that may aect the
paent’s safety or monitoring performance. It is recommended that the oximeter should be inspected at
least once a week. Stop using the oximeter when there is obvious damage.
Necessary maintenance must be performed by qualied service technicians ONLY. Users are not permied
to maintain it themselves.
The oximeter cannot be used together with oximeters not specied in this user manual.
This oximeter is calibrated before leaving the factory.
1.2 Warning
Explosive hazard - do NOT use the oximeter in an environment where inammable gas such as ignitable
anaesthec agents, is present.
Do NOT use the oximeter while the paent is being measured by MRI or a CT scan.
Do NOT use the oximeter on paents who are allergic to rubber.
Follow local laws and regulaons when disposing of the oximeter, accessories, and packaging (including
baeries, plasc bag, foam and paper boxes).
Please check the packaging before using for the rst me to ensure the oximeter and accessories are in
accordance with the packing list.
1.3 Aen
Keep the oximeter away from dust, vibraon, corrosive substances, explosive materials, high temperature
and moisture.
If the oximeter gets wet, please stop operang it.
When the oximeter is moved from a cold environment to a warm or humid environment, please do not use
it immediately but rather wait 20 minutes for the oximeter to adjust to the ambient temperature.
Do NOT operate the buon on the front panel with a sharp object.
High temperature or high-pressure steam disinfecon of the oximeter is not permied. Refer to “Cleaning,
disinfecon and maintenance” in secon 8 in the manual.
Do not submerge the oximeter in liquid. When it needs cleaning, please refer to “Cleaning, disinfecon and
maintenance” in secon 8 in the manual.
Fingers which are too thin or too cold, are likely to aect the normal measurement of a paent’s SpO2and
pulse rate. Clip the oximeter onto a thicker nger such as the thumb or middle nger and ensure the nger
is posioned deep enough into the probe for measurement to be eecve.
Do not use the oximeter on infants or neonatal paents.
The oximeter is suitable for children over four years old and adults. Paents should weigh between 40kg
and 110kg.
The oximeter may not work for all paents. Disconnue use if you are unable to achieve stable readings.
The data updates in less than 5 seconds and changes according to individual pulse rates.
If abnormal condions appear on the screen during the testing process, remove the oximeter and then
reinsert the nger to restore normal use.
The oximeter has a normal lifespan of 3 years since using for the rst me.
The lanyard aached to the oximeter is made from non-allergenic material. Disconnue using the lanyard if
a paent appears sensive to it. In addion, pay aenon to the use of the lanyard and avoid wearing it
around the neck so as to not cause harm.
The oximeter does not have an abnormal reading alarm funcon. Do not use the oximeter in situaons
where alarms are required.
Change the baeries when the low-baery icon displays on screen.
Baeries must be removed if the oximeter is going to be stored unused for more than 1 month as baeries
may leak.
A exible circuit connects the two parts of the oximeter. Do not twist or pull on the connecon.
1.4 IndicafUse
The Fingerp Pulse Oximeter is a non-invasive oximeter intended for spot-checking oxygen saturaon of arterial
haemoglobin (SpO2) and the pulse rate of adult and paediatric paents.
2 Overview
The oximeter is simple to operate, portable and uses very lile baery power. It is only necessary for the paent
to insert a nger into the ngerp photoelectric sensor for a diagnosis. The screen will display the measured
value of Haemoglobin Saturaon (SpO2) and Pulse Rate.
2.1 Classica
Class II a (MDD93/42/EEC IX Rule 10)
Class II (U.S.FDA)
2.2 Features
Simple to operate
Portable and lightweight (approx. 50g, including baeries) with a handy lanyard
Low power consumpon
The oximeter will automatically power owhen no signal is received in 5 seconds
Low-baery warning indicator
Pulse strength and rate is displayed
SpO2 percentage is displayed
2.3 Majr Applicas and Spe f Applica
The Classic Fingerp Pulse Oximeter is used to measure human Haemoglobin Saturaon (SpO2) and pulse rate -
the so-called the O2 concentraon in the blood. It is an important bio-parameter for respiraon.
The oximeter is suitable for use in home and hospital environments (including clinical use in internist/surgery
and intensive care).
This oximeter is NOT intended for connuous monitoring.
The ximeter ist suitable fse in cns supervisi paents.
The prlem f verrang cld emerge if the paent is sering frm txicsis caused by carbn
mnxide. The ximeter ist recmmended t used under this circumstance.
2.4 Envirnment Requirements
Storage Environment
Temperature: -40℃~+60℃
Relave humidity: 95%
Atmospheric pressure: 500hPa~1060hPa
Operang Environment
Temperature: 10℃~40℃
Relave Humidity: 75%
Atmospheric pressure: 700hPa~1060hPa
3 Principle and Cau
3.1 Principlef Measurement
An experienced formula of data processing is established by making use of Lambert Beer Law according to
Spectrum Absorpon Characteriscs of Reducve Haemoglobin (Hb) and OxyHaemoglobin (HbO2) in glow and
near-infrared zones. The operation principle of the oximeter is: Photoelectric OxyHaemoglobin Inspecon
Technology which is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two
light beams of dierent wavelengths can be focused on the human ngerp through a perspecve clamp
nger-type sensor. The measured signal is obtained by a photosensive element. The informaon acquired is
displayed on screen through the electronic circuits and microprocessor.
Figure 1. Operang Principle
3.2 Cau
The nger should be placed properly (see Figure 5) or else it may cause inaccurate measurement.
The SpO2sensor and photoelectric receiving tube should be arranged such that the paent’s arteriole is
positioned in-between them．
Do not use the oximeter on the same limb that is receiving an intravenous injecon/drip, or which is
restricted due to a blood pressure cuor a compression bandage.
Make sure the opcal path is free from any pacle obstacles like rubberised fabric or dirt.
Excessive ambient light may aect the measuring result. This includes uorescent lamps, dual ruby light,
infrared heaters, direct sunlight etc.
Strenuous acon of the paent or extreme electrosurgical interference may also aect the accuracy.
Ensure the ngernail of the paent is clean and free of nail polish, gel covering, acial nail etc.
3.3 Clinical Restric
As the measurement is taken based on arteriole pulse, substanal pulsang blood ow of the paent is
required. For a paent with a weak pulse due to shock, low ambient/body temperature, major bleeding or
use of a vascular contracng drug, the SpO2waveform (PLETH) will decrease. In this case, the measurement
will be more sensive to interference.
For those with a substanal amount of staining diluon drug (such as methylene blue, indigo green and
acid indigo blue), carbon monoxide Haemoglobin (COHb), methionine (ME+Hb) or Thiosalicylic
Haemoglobin, and for some with icterus problem, the SpO2determinaon with this oximeter may be
inaccurate.
Drugs such as dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed
for serious error of SpO2measures.
As the SpO2value serves as a reference value for the judgement of anaemic anoxia and toxic anoxia, some
paents with serious anaemia may also report good SpO2measurement.
4Technical Specicns
4.1 Display Frmat: Digital tube Display
4.2 SpO2Measuring Range: 0% - 100%
4.3 Pulse Rate Measuring Range: 30 bpm - 250 bpm
4.4 Pulse Intensity Display: column display
4.5 Pwer Requirements: 2 ×1.5V AAA alkaline baery
4.6 Pwer Cnsumpn: Less than 25 mA
4.7 Reslun: 1% for SpO2and 1 bpm for Pulse Rate
4.8 Measurement Accuracy: ±2% accuracy within 70%-100% SpO2range. Accuracy for results that are less
than 70% is unspecied.
4.9 Measurement Perfrmance in Weak Filling Cndi SpO2and pulse rate can be shown correctly when
the pulse-lling rao is 0.4%. SpO2error is ±4%, pulse rate error is ±2 bpm or ±2% (select the larger value).
4.10 Resistance tsurrding light: The deviaon between the value measured in the condion of
man-made light or indoor natural light and that of darkroom is less than ±1%.
4.11 Funcswitch: The oximeter powers owhen there is no nger in the oximeter.
4.12 Opcal Sens: Red light (wavelength is 660nm, 6.65mW); Infrared (wavelength is 880nm, 6.75mW)
5 Acceries
1 lanyard
2 AAA baeries
1 user manual
6 Installan
6.1 Vief the Frnt Panel
Figure 2. Front View Figure 3. Battery Installaon
6.2 Baery
Observe the rectlarity when inserting the baeries as improper inseron may damage the oximeter.
Step 1. Refer to Figure 3. and insert the 2 AAA baeries.
Step 2. Replace the cover.
6.3 Aaching the Lanyard
Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the rst one and pull to ghten it.
Figure 4. Aaching the lanyard Figure 5. Correct finger posioning
7 Operng Guide
7.1 Insert the 2 baeries correctly according to the polarity and then replace the cover.
7.2 Open the clip by pressing the hinge end of the oximeter.
7.3 As shown in Figure 5. posion the paent’s nger on the rubber cushions of the oximeter ensuring the
nger is set deep within the oximeter with the ngernail facing upwards.
7.4 Press the switch buon once on front panel.
7.5 Do not shake the nger. The paent must be sll during the process and should not move around.
7.6 The results will display on screen and will connuously update.
7.7 Press the buon to reset the oximeter.
Fingernail and the luminescent tube sld be the same side.
8Cleaning, disinfecn and maintenance
8.1 Change the baeries when the low baery indicator is displayed on screen.
8.2 Clean the surface of the oximeter before using it. Wipe the surface with a clean, socloth that has been

Pulse Oximeter
PO6L
User Manual
CE0197
Syringa UK Ltd
www.medigenix.co.uk
[e-mail]
Unit G Daux Road, Billingshurst, RH14 9SR, United Kingdom
iHealth Labs Europe SAS
36 Rue de Ponthieu, 75008, Paris , France

8.3 dampened with medical alcohol. Then let it air dry or dry it with a clean cloth. Do NOT spray any liquid
directly onto the oximeter. When cleaning the oximeter with water, ensure the temperature is not higher
than 60°C.
8.4 Use medical alcohol to disinfect the oximeter after use to prevent cross-contamination when using next
time.
8.5 Remove the batteries if the oximeter is not going to be used for a long time.
8.6 The best storage environment for the oximeter is -40 60°C ambient temperature and less than 95%
relative humidity.
8.7 Users are advised to calibrate the oximeter termly (or according to the calibrating program of hospital
8.8 High-pressure sterilisation cannot be used on the oximeter. Do not immerse the oximeter in liquid.
It is recommended that the oximeter should be kept in a dry environment. Humidity may reduce the
useful life of the oximeter, or even damage it.
9 Troubleshooting
Trouble
Possible Reason
Solution
The SpO2and Pulse
Rate are not being
displayed normally
1. The finger is incorrectly positioned.
2. The patient’s SpO2is too low to be
detected.
3. There is nail polish or false nails.
1. Position the finger correctly and
try again.
2. Try again. Go to a hospital for a
diagnosis if you are certain the
oximeter is working all right.
3. Ensure fingernail is free of polish
or false nail.
The SpO2and Pulse
Rate are not
displayed stably
1. The finger is not placed deeply
enough inside the oximeter.
2. The finger is shaking or the patient is
moving.
1. Position the finger correctly and
try again.
2. Keep the patient calm and still.
The oximeter will not
turn on
1. The batteries are drained or almost
drained.
2. The batteries are not inserted
properly.
3. The oximeter has malfunctioned.
1. Change batteries.
2. Reinstall batteries correctly.
3. Please contact Syringa UK Ltd.
The display is
suddenly off
1. The oximeter will automatically
power off in 5 seconds when it
receives no signal.
2. The batteries are almost drained.
1. This is normal.
2. Change batteries.
10 Key of Symbols
Symbol
Description
Type BF
Refer to the user manual
SpO2%
The pulse oxygen saturation expressed as a percentage (%)
PRbpm
Pulse rate - beats per minute (bpm)
Low battery indicator
No finger inserted or detected
An indicator of an inadequate signal
battery positive electrode
battery cathode
Power switch
SN
Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22
Ingress of liquids rank
This item is compliant with Medical Oximeter Directive 93/42/EEC of June
14, 1993, a directive of the European Economic Community.
European Representative
11 Function Specification
Display Information
Display Mode
Pulse Oxygen Saturation (SpO2)
Digital
Pulse Rate (BPM)
Digital
Pulse Intensity (bar graph)
Digital bar graph display
SpO2Parameter Specification
Measuring range
0%~100%, (the resolution is 1%).
Accuracy
70%~100%: ±2%. Below 70%: unspecified
Optical Sensor
Red light (660nm wavelength)
Infrared (880nm wavelength)
Pulse Parameter Specification
Measuring range
30bpm~250bpm (the resolution is 1 bpm)
Accuracy
±2bpm or ±2% - select larger
Pulse Intensity
Range
Continuous bar graph display: the higher display indicates
the stronger pulse
Battery Requirement
1.5V (AAA size) alkaline batteries × 2
Battery Useful Life
Two batteries can work continually for 24 hours
Dimensions and Weight
Dimensions
57(L) × 31(W) × 32(H) mm
Weight
About 50g (with the batteries)
Appendix: Electromagnetism Compatibility
Guidance and Manufacture’s declaration – electromagnetic emission
The PO6L is intended for use in the electromagnetic environment specified below.
The user should ensure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The PO6L uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emission
CISPR 11
Class B
The PO6L is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage
fluctuations/ flicker
emissions
IEC 61000-3-3
N/A
Guidance and Manufacture’s declaration – electromagnetic immunity
The PO6L is intended for use in the electromagnetic environment specified below.
The user should ensure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 KV contact
8 kV air
Floors should be wood, concrete or ceramic
tile. If floor is covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
1 kV differential
mode
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency
(50/60Hz)
Magnetic field
IEC-61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level.
Guidance and Manufacture’s declaration – electromagnetic immunity for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
The PO6L is intended for use in the electromagnetic environment specified below.
The user should ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the PO6L than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,ashould be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the PO6L is used exceeds the applicable RF compliance level above, the PO6L should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the PO6L.
bIf the frequency range is over 150 kHz to 80 MHz, then field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the PO6L
The PO6L is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the PO6L as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance in metres (m) according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.39
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
P
V
d





=
1
5.3
P
E
d





=
1
5.3
P
E
d





=
1
7
P
V
d





=
1
5.3
P
E
d





=
1
5.3
P
E
d





=
1
7